Renee Blanco-Fisher

Quality Assurance and Compliance leader with over 20 years of experience. In that time, I have effectively, • Global management of employees included: (1) development of junior staff for the achievement of their career aspirations (2) successfully achieving yearly department objectives highlighted at annual meetings. I am well-versed in all Therapeutic Areas (CV, Oncology, Rare Diseases, Immunology, Biologics, etc.) • Supervised Quality professionals in the delivery of compliance for the Western Region (US, Canada, and South America). • Managed a departmental budget of 1.5 million: under departmental budget by $200,000 • Established a GCP Global Quality Assurance department in start-up/small, middle/large biotechnology/pharmaceutical companies: developing SOPs, auditing tools, and standardized QA interactions with internal stakeholders, i.e., Clinical Development. • Conducted many GCP audits: investigator site, vendor audits (i.e. imaging, CRO, PH I facility, Labs), due diligence, for-cause/directed, qualification/requalification, and internal company process audits. On average two (2) to three (3) audits were conducted monthly (2000-2015 and 2016-present 5 a year). In addition, I have conducted GMP and GLP audits for manufacturing drug products and review of sample receipt, processing, and storage. • Expert in the Inspection Readiness Process: development of procedures and tools, communication, and guidance to internal stakeholders, hosting an inspector, preparation of sites/sponsor for Regulatory Authority Inspections, and mock inspections.